Department of Laboratory Medicine, Renmin Hospital of Wuhan University, Wuhan, China.
Department of Laboratory Medicine, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China.
J Clin Lab Anal. 2021 Jun;35(6):e23816. doi: 10.1002/jcla.23816. Epub 2021 May 12.
Serum biomarkers have been widely adopted in clinical practice for assisting lung cancer diagnoses, therapeutic monitoring, and prognostication. The function of a well-performing tumor biomarker depends on a reliable reference interval (RI) with consideration of the study subjects' age, gender, and geographical location. This study aimed to establish a RI for each of 6 lung cancer biomarkers for use in the whole country of China on Mindray platform.
The levels of serum 6 lung cancer biomarkers-namely progastrin-releasing peptide (ProGRP), neuron-specific enolase (NSE), squamous cell carcinoma antigen (SCC), carcinoembryonic antigen (CEA), cytokeratin-19 fragment (CYFRA21-1), and human epididymis protein 4 (HE4)-were measured utilizing the chemiluminescence immunoassay on the Mindray CL-6000i platform following the laboratory standard operating procedures in apparently healthy Chinese individuals on large cohort, multicenter, and geographical consideration bases. The CLSI EP28-A3C guideline was followed for the enrollment of study subjects.
The age-stratified, gender-specific RIs for ProGRP, NSE, SCC, CEA, CYFRA21-1, and HE4 lung cancer biomarkers in the Chinese population have been established as described in the results and discussion in this work. In addition, various levels of the six lung cancer biomarkers among nine geographical locations in China have been observed.
The sample volume of study cohort, age, and geographical location should be considered upon establishing a reliable biomarker RI. A RI for each of six lung cancer biomarkers has been established. The results from this study would be helpful for clinical laboratories in interpreting the analytical results and for clinicians in patient management.
血清生物标志物已广泛应用于临床实践，以辅助肺癌的诊断、治疗监测和预后判断。一个性能良好的肿瘤标志物的功能取决于一个可靠的参考区间（RI），同时要考虑研究对象的年龄、性别和地理位置。本研究旨在为迈瑞平台上的 6 种肺癌标志物中的每一种建立一个在中国全国范围内使用的 RI。
利用化学发光免疫分析法，按照实验室标准操作程序，在明显健康的中国人群中，基于大样本量、多中心和地理考虑的基础上，在迈瑞 CL-6000i 平台上测量血清 6 种肺癌标志物-胃泌素释放肽前体（ProGRP）、神经元特异性烯醇化酶（NSE）、鳞状细胞癌抗原（SCC）、癌胚抗原（CEA）、细胞角蛋白 19 片段（CYFRA21-1）和人附睾蛋白 4（HE4）的水平。研究对象的纳入遵循 CLSI EP28-A3C 指南。
本研究建立了中国人群中胃泌素释放肽前体（ProGRP）、神经元特异性烯醇化酶（NSE）、鳞状细胞癌抗原（SCC）、癌胚抗原（CEA）、细胞角蛋白 19 片段（CYFRA21-1）和人附睾蛋白 4（HE4）肺癌标志物的按年龄和性别分层的 RI，并在本工作的结果和讨论中进行了描述。此外，还观察到了中国 9 个地理位置中 6 种肺癌标志物的不同水平。
在建立可靠的生物标志物 RI 时，应考虑研究队列的样本量、年龄和地理位置。本研究为每个肺癌标志物建立了一个 RI。本研究的结果将有助于临床实验室解释分析结果，也有助于临床医生对患者进行管理。
